Effects of Dietary Protein Intake and Resistance Training on Retention of Fat Free Mass During Weight Loss in Adults Over 50 with Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- Class Attendance
研究概览
简要总结
The purpose of this study is to examine the separate and combined effects of a high-protein (HP) diet and resistance training (RT) on body composition and potential biological moderators of body weight in women and men >50y. All participants will receive dietary physical activity guidance through our group-based weight loss program, State of Slim (SOS). The SOS program will be delivered via the Zoom videoconferencing platform. These participants will be randomized to receive either a counseling-based HP diet plan or RT plan. Body composition assessments at 8 wk will identify responders and non-responders; the latter will be re-randomized to "augment" (HP: add protein supplements; RT: supervise RT) or "combine" (HP with protein supplements + supervised RT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or Female
- •Age ≥50 years
- •Post-menopausal if Female
- •BMI of 30-50 kg/m2 for ambulatory participants (less than or equal to 350 lbs.)
- •BMI of 25-50 kg/m2 for wheelchair users (less than or equal to 350 lbs.)
- •Ambulatory with or without a walking device or use of a manual wheelchair for mobility.
排除标准
- •Untreated hyper or hypothyroidism.
- •Cancer (except basal cell).
- •Gastrointestinal disorders affecting food intake.
- •<3 months of stable use of medications that affect metabolism, body weight, energy expenditure or appetite.
- •Current eating disorder (e.g., binge eating disorder, anorexia, or bulimia).
- •Any medical condition for which following a HP diet and/or 70 minutes of exercise daily would be inadvisable.
- •Uses a powered wheelchair for mobility.
- •Has a pacemaker or any other life-sustaining medical implant.
结局指标
主要结局
Class Attendance
时间窗: Baseline through week 52.
Class Attendance will be tracked to determine clinical trial feasibility.
2nd Stage Intervention Preference
时间窗: Week 8
Participant preferences for 2nd stage interventions will be measured at week 8 by answering a 5-point Likert question with '1' and '5' representing a strong preference for either intervention and '3' representing no intervention preference.
Recruitment and Retention Rates
时间窗: Baseline through week 52.
Rates of study recruitment and retention will be tracked to determine clinical trial feasibility.
1st Stage Intervention Preference
时间窗: Baseline
Participant preferences for 1st stage interventions will be measured at baseline by answering a 5-point Likert question with '1' and '5' representing a strong preference for either intervention and '3' representing no intervention preference.
1st Stage Treatment Credibility
时间窗: Baseline.
Perceived credibility of 1st stage interventions will be measured at baseline with the Credibility/Expectancy Questionnaire.
2nd Stage Treatment Credibility
时间窗: Week 8.
Perceived credibility of 2nd stage interventions will be measured in non-responders to 1st stage interventions at week 8 with the Credibility/Expectancy Questionnaire.
次要结局
- Body Weight(Baseline, Weeks 8, 16, and 52)
- Fat mass(Baseline, Weeks 8, 16, and 52)
- Fat free mass(Baseline, Weeks 8, 16, and 52)
研究者
Drew Sayer
Primary Investigator
University of Alabama at Birmingham